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Post by Clozaril lab work on Mar 24, 2020 9:45:58 GMT -8
Did anyone get the info about REMS waiving lab work for Clozaril patients? From my understanding the REMS system will not block a pharmacy from providing the medication however they are still encouraging individuals able to obtain lab work to do so. My understanding is that they are not "waiving" the labs, rather they are understanding that some individuals may be unable to get it as scheduled. Anyone understand or hear anything different?
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Post by lorna on Mar 25, 2020 5:57:10 GMT -8
(PS for those getting use to this forum -- to respond to a posted thread, you select "quote" -- it's not that intuitive on how to reply!)
On 3/22/20, the FDA issued new guidance that allows for clozapine to be dispensed without a current ANC for the duration of the declared Public Health Emergency. The FDA announcement is here: www.fda.gov/media/136317/download
Did anyone get the info about REMS waiving lab work for Clozaril patients? From my understanding the REMS system will not block a pharmacy from providing the medication however they are still encouraging individuals able to obtain lab work to do so. My understanding is that they are not "waiving" the labs, rather they are understanding that some individuals may be unable to get it as scheduled. Anyone understand or hear anything different? |
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Post by shannon RN on Mar 25, 2020 8:23:02 GMT -8
This is the first I'm seeing this, THANK YOU
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Post by Catherine on Mar 25, 2020 10:14:36 GMT -8
Thank you for this information. I will let the team know that is going on.
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Post by Cindy on Mar 26, 2020 7:43:39 GMT -8
Yes, We worked with our pharmacy this week and received a month on all patients on Clozaril-- no lab needed. Dr. and pharmacist are having conversations about feasibility and comfortability regarding this.... We successfully got to receive a months worth.
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Post by steve56 on Mar 31, 2020 5:08:58 GMT -8
(PS for those getting use to this forum -- to respond to a posted thread, you select "quote" -- it's not that intuitive on how to reply!)
On 3/22/20, the FDA issued new guidance that allows for clozapine to be dispensed without a current ANC for the duration of the declared Public Health Emergency. The FDA announcement is here: www.fda.gov/media/136317/download
Did anyone get the info about REMS waiving lab work for Clozaril patients? From my understanding the REMS system will not block a pharmacy from providing the medication however they are still encouraging individuals able to obtain lab work to do so. My understanding is that they are not "waiving" the labs, rather they are understanding that some individuals may be unable to get it as scheduled. Anyone understand or hear anything different? |
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Post by steve56 on Mar 31, 2020 5:11:12 GMT -8
This resource from SAMHSA's SMI Advisor addresses managing Clozaril and other salient topics during Covid-19 crisis. smiadviser.org/about/covid |
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Post by sarahs on Mar 31, 2020 13:28:16 GMT -8
I'm trying to continue to obtain labs per protocol but its nice to have the wiggle room
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